TRINTEK 10 GLYCERYL TRINITRATE TRANSDERMAL PATCH

PDF Transcript

Package leaflet: Information for the patient
TRINTEK 10 Glyceryl Trinitrate Transdermal Patches
glyceryl trinitrate
Read all of this leaflet carefully before you start using this medicine because it contains
important information for you.
-

Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them,
even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.

What is in this leaflet
1.
2.
3.
4.
5.
6.

What TRINTEK is and what it is used for
What you need to know before you use TRINTEK
How to use TRINTEK
Possible side effects
How to store TRINTEK
Contents of the pack and other information

The full name of your product is TRINTEK 10 Glyceryl Trinitrate Transdermal Patch, however,
throughout the leaflet it will be referred to as TRINTEK.

1.

What TRINTEK is and what it is used for

TRINTEK is an adhesive (stick on) patch containing the active substance glyceryl trinitrate which is
released through the skin and into the body. Glyceryl trinitrate is one of a group of medicines called
nitrates which help to widen blood vessels, making blood flow more easily.
TRINTEK patches are used by itself or with other medicines to prevent angina, but are not used to
relieve a sudden attack of angina. Angina is a painful tightness in the chest which occurs when the
muscles of the heart are not receiving enough blood and oxygen. Pain may also be felt in the neck and
arms.

2.

What you need to know before you use TRINTEK

Do not use TRINTEK if you:
•
are allergic to glyceryl trinitrate or other medicines or foods containing nitrates, or any of the
other ingredients in the patch (listed in section 6). An allergic reaction may cause a rash, itching
or shortness of breath,
•
suffer from very low blood pressure or blood volume,
•
have obstructive heart disease e.g. narrowing of the valves in your heart (stenosis),
inflammation of the heart lining (constrictive pericarditis), thickening of the heart muscle
(hypertrophic cardiomyopathy), build-up of fluid or blood in the space between the heart muscle
and covering sac of the heart (pericardial tamponade),
•
are taking medicines for erectile dysfunction, such as sildenafil, as a severe and possibly
dangerous fall in blood pressure could occur,
•
are being treated for severe anaemia (have low levels of haemoglobin – a substance contained
within the red blood cells which is responsible for carrying oxygen around the body),
•
have blood loss or you are in shock,

•
•

have a head injury, raised pressure or bleeding in the brain,
have an eye condition called closed-angle glaucoma.

Warnings and precautions
Talk to your doctor or pharmacist before using TRINTEK if you have any of the following
conditions:
•
have had a recent heart attack or heart failure,
•
are being treated for lung disease,
•
are suffering from any disorder of the thyroid gland, liver or kidney,
•
are suffering from malnutrition (severe lack of food),
•
hypothermia (very low body temperature),
•
sometimes feel dizzy or faint, particularly when getting up from lying or sitting (postural
hypotension).
If you are having certain procedures which use magnetic or electrical fields like a magnetic resonance
imaging scan (MRI scan), cardioversion or defibrillation (an electric shock used to return the heart to
its normal rhythm) or diathermy (where body tissues are heated electrically to treat or help certain
conditions), you will need to remove your patch.
Children and adolescents
TRINTEK patches are not suitable for use in children.
Other medicines and TRINTEK
Some medicines can affect the way TRINTEK works, or TRINTEK can affect other medicines taken
at the same time.
Do not take medicines for erectile dysfunction such as sildenafil while you are using TRINTEK, as a
severe and possibly dangerous fall in blood pressure could occur. This could result in collapse,
unconsciousness or even death.
Tell your doctor if you are taking, have recently taken or might take any other medicines including any
of the following:
•
medicines for lowering blood pressure, water retention or for heart problems like calcium
channel blockers, ACE inhibitors, beta-blockers, and diuretics,
•
medicines for anxiety or depression (e.g. tricyclic antidepressants, tranquillisers),
•
amifostine (a medicine used to reduce the side effects of certain cancer treatments or
radiotherapy,
•
medicines for migraine containing ergotamine. Taking TRINTEK with dihydroergotamine, a
medicine used to treat migraine, can affect the blood vessels in the heart
•
acetylsalicylic acid (aspirin),
•
non-steroidal anti-inflammatory drugs, NSAIDs (used to treat pain and inflammation).
TRINTEK with alcohol
Drinking alcohol when using TRINTEK is not recommended, as this can increase the fall in blood
pressure that may occur when using the patch.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before using this medicine.
You should not use TRINTEK if you are pregnant, especially in the first three months. There is
limited information on the presence of this medicine in breast milk. Your doctor will discuss with you
whether to stop breast-feeding or to not take this medicine.

Driving and using machines
TRINTEK may sometimes impair your reactions or cause dizziness, light-headedness upon standing
or fainting or blurred vision, especially at the start of treatment or when the dose is adjusted. If you
experience these symptoms, do not drive or use any tools or machinery.

3.

How to use TRINTEK

Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
Adults (including the elderly)
This patch is used for preventing angina and not for treating a sudden attack. Your doctor will
have prescribed another medicine to treat sudden attacks of angina.
•
TRINTEK patches are for use in adults only and are not recommended for use in children.
•
The recommended starting dose is one TRINTEK 5 transdermal patch per day. Your doctor may
increase the dose gradually if necessary.
•
If higher doses are required to prevent your angina, a TRINTEK 10 transdermal patch or a
TRINTEK 15 transdermal patch may be prescribed. The maximum dose is one TRINTEK 15
transdermal patch per day.
•
You may be told to wear a patch all of the time or for only part of the day. Don't forget to follow
your doctor's instructions exactly.
•
Never use more patches or wear them for longer than your doctor has advised. You should
check with your doctor if you are not sure.
•
If you are also taking other medicines for your angina your doctor will advise you on the best
time to take them.
•
Select a clean, dry, relatively hairless area on either side of your chest. If hair is likely to
interfere with patch adhesion or removal, it can be clipped but not shaved.
•
Take care to avoid areas with cuts or irritations.
•
Do not apply the patch immediately after showering or bathing. It is best to wait until you are
certain the skin is completely dry.
•

Do not tear or cut your patch.
How to apply the patch
1.
Each TRINTEK patch is individually sealed in a protective package.
•
Open the pouch at the tear mark.
•
Carefully remove the patch.
•
The patch is printed with the wording TRINTEK 10, the patch size (16 cm2) and the amount
delivered in 24 hours (10 mg in 24 hr).
•
The patch is attached to a clear peelable liner.
•
The liner has a slit which divides it into two strips.
•
Hold the patch with the wording facing away from you.
•
The slit should now be facing toward you.
•
Rotate the patch as necessary to place the slit in an up and down position.
TRINTEK10
10 mg/24 hr
(16 cm2)

2.

Bend both sides of the clear peelable liner away from you at the slit.

3.

Slowly peel off only one of the strips of the clear liner. Do not touch the exposed side of the
patch.

4.

Using the remaining strip as a ‘handle’, apply the sticky side of the patch to the skin. Press the
sticky side on the chosen skin site and smooth down.

5.
•
•
•
•
•

Fold back the unattached side of the patch.
Grasp the remaining strip and remove it while applying the remainder of the patch to the skin.
Press the patch on the skin and smooth down.
Once the patch is in place, do not test how well it is stuck on by pulling on it.
When the TRINTEK patch is applied to your body, the active ingredient contained in the patch
begins to flow from the sticky surface through your skin at a regular rate.

6.

After applying the patch, wash your hands to remove any of the medicine.

Please Note: Once the patch is in place, swimming, showering or bathing should not affect it.
However, if the patch does fall off, dispose of it carefully and put a new patch on a different skin site.
Changing your patch
Remove your patch at the time recommended by your doctor. Dispose of the used patch
carefully as it will still contain some of the active ingredient. Fold the patch in half with sticky
sides together before disposing it.

•

•

Place a new patch on a different skin site (following steps 1 through to 6 above) at the time
recommended by your doctor.

•

Try not to apply the new patch to the same area of the skin used for the previous patch and leave
one week before putting a patch in an area of the skin already used.

If you accidentally use too many patches
If you accidentally use too many patches remove the extra patches, then tell your doctor immediately
or go to the nearest hospital casualty department, even if you do not feel unwell. Always take the
labelled medicine package with you, whether there is any TRINTEK left or not.

Too much glyceryl trinitrate can cause you to feel sick, be sick and feel restless. Other symptoms
include warm, flushed skin, blurred vision, headache, fainting, confusion, low blood pressure with a
fast or irregular heart rate which may make you feel light-headed or cause you to faint or collapse.
If you forget to use your patch
If you forget to apply your patch in the morning you may do so later in the day. If you have missed a
day do not apply extra patches to make up for the day missed.
If you stop using the patch
Do not stop using the patches suddenly as this could cause an angina attack or a heart attack. Always
consult your doctor first.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
All medicines including TRINTEK can cause allergic reactions. You should contact your doctor
immediately if you experience any of the following symptoms after taking TRINTEK:
•
sudden wheeziness, shortness of breath
•
difficulty in breathing or dizziness
•
swelling of the eyelids, face, lips, tongue or throat
•
widespread rash, itchy skin or nettle rash.
Other possible side effects:
Very common (may affect more than 1 in 10 people):
•
Nausea (feeling sick).
•
Vomiting (being sick).
Common (may affect up to 1 in 10 people):
•
Headache, especially at the start of treatment. This usually wears off after a few days but you
can take some mild pain killers (such as paracetamol) for this. If the headaches continue or are
very severe, talk to your doctor.
Uncommon (may affect up to 1 in 100 people):
•
Skin irritation, a burning sensation, itchy rash or reddening where you have placed the patch. It
is therefore important that you choose a different place on your skin to put the patch every day.
•
Inflammation of the skin with symptoms such as red, itchy, scaly skin (contact dermatitis).
Rare (may affect up to 1 in 1,000 people):
•
Flushing.
•
Rapid heartbeat or pulse (tachycardia).
•
Faintness, dizziness or light-headedness may occur, especially when suddenly rising from the
lying position (orthostatic or postural hypotension).
Very rare (may affect up to 1 in 10,000 people):
•
Dizziness.
Not known (frequency cannot be estimated from available data):
•
Fast or irregular heartbeats called palpitations.
•
Rash.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet.
You can also report side effects directly via the internet at www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.

5.

How to store TRINTEK

•
•

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date, which is stated on the carton and sachet. The
expiry date refers to the last day of that month.
Do not store above 25°C. Do not refrigerate.
Do not store patches once they have been removed from the protective pouch.

•
•

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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